Company ยท US
Genzyme Surgical Product (Genzyme Biosurgery)
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2000. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 |
| CAC | Apparatus, Autotransfusion | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| MDM | Instrument, Manual, Surgical, General Use | 1 |
| MOP | Rotator, Prosthetic Heart Valve | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 13, 2000 | K001440 | NEXTSTITCH CARDIOVASCULAR VALVE SUTURE Genzyme Surgical Product (Genzyme Biosurgery) | GAT |
| Jun 12, 2000 | K001434 | 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE Genzyme Surgical Product (Genzyme Biosurgery) | GAT |
| Sep 3, 1999 | K992088 | BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE Genzyme Surgical Product (Genzyme Biosurgery) | GAM |
| Jul 20, 1999 | K991416 | ENDOSCOPIC CAMERA Genzyme Surgical Product (Genzyme Biosurgery) | GCJ |
| Jun 22, 1999 | K991191 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE Genzyme Surgical Product (Genzyme Biosurgery) | GAM |
| Mar 30, 1999 | K990062 | SAPHLIFT Genzyme Surgical Product (Genzyme Biosurgery) | MDM |
| Dec 18, 1998 | K982712 | RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 Genzyme Surgical Product (Genzyme Biosurgery) | CAC |
| Aug 7, 1998 | K980016 | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE Genzyme Surgical Product (Genzyme Biosurgery) | MOP |
| Jul 7, 1998 | K981322 | CUTALON NYLON POLYAMIDE SURGICAL SUTURE Genzyme Surgical Product (Genzyme Biosurgery) | GAR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||